Sodium BicarbonateNCT06098794
Effect of Sodium Bicarbonate on Exercise Performance
A study testing Sodium Bicarbonate in people with Sodium Bicarbonate, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
This was a randomized, double-blind, placebo controlled, crossover trial. The study aimed to assess the effect of sodium bicarbonate on the ability to perform a repeated sprint task by female football players. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sodium Bicarbonate
- What is being tested?
- Sodium Bicarbonate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Oct 2021to 27 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Football players
- Regularly training with a weekly microcycle consisting of 3 to 5 training sessions and 1 game at the weekend
- Able to provide informed consent
Who cannot join
- Injury occurrence in the month previous to data collection
- Ergogenic supplements consumption in the month previous to data collection
- Having known intolerance to sodium bicarbonate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Sodium Bicarbonate Supplementation on Intense Exercise Performance
This was a randomized, double-blind, placebo controlled, crossover trial. The study aimed to assess the effect of sodium bicarbonate on the ability to perform a repeated sprint task by female football players. The researches hypothesis was that sodium bicarbonate increases the ability to remove lactic acid from muscle cells reducing its intracellular accumulation and increasing energetic efficiency resulting in the increase of peak power output, mean power output, or total work or in the decrease of the sprint decrement in each set of the repeated sprints task.
Read the detailed description
Experimental design: The study consisted of a randomized, double-blind, controlled, crossover trial where 11 female football players performed, in a randomized order, two repeated sprints tasks in a cycle ergometer, after having ingested either sodium bicarbonate (SB) or placebo (PL). Body composition of the athletes was characterized by bioelectrical impedance analysis with a single frequency (50 kHz) device (BIA 101 Anniversary, Akern, Florence, Italy) before the exercise sessions. Data collection was separated by a period of at least one week within a period of time not exceeding one month and performed at the same time of the day for each participant. Data regarding performance, blood lactate accumulation, pulmonary gas exchange, heart rate (HR), muscle oxygenation and neuromuscular fatigue were collected during these two sessions.
Supplementation protocol: The participants ingested capsules containing 0.3 g/kg of body weight of SB or cellulose as PL divided into two doses. The first intake (0.2 g/kg) occurred 2 h before the beginning of the protocol, and the second (0.1 g/kg) occurred 1 h later. Possible gastrointestinal symptoms associated with supplement ingestion were controlled with a questionnaire based on the questionnaire applied by Miller et al. (2016).
Repeated sprints protocol: The RSA protocol was performed in a cycle ergometer (Monark Ergomedic 894 E, Monark Exercise AB, Vansbro, Sweden) and was composed of 3 sets of 6 sprints with 6 s duration with a workload of 4% of the body mass. Repetitions were separated by 24 s of active recovery, and participants were conceded 5 min of passive recovery to rest between sets. The protocol was preceded by a 5-min warm-up in which athletes pedalled at a speed of 60 to 70 rpm.
Performance Measurements: Performance was evaluated by monitoring peak power output, mean power output, total work and the sprint decrement in each set of the two repeated sprints task.
Blood lactate accumulation: Lactate concentration was assessed (Lactate Pro 2, KDK Corporation, Kyoto, Japan) in capillary blood from the ear lobe before the beginning of each protocol, 1 min after the end of each set, and at min 1 and every 2 min after the tasks were completed, until the value started to decrease. At the end of the tasks, the maximal values achieved were considered for analysis.
Pulmonary gas exchange and heart rate: Oxygen uptake, carbon dioxide production and ventilation (VO2, VCO2, VE, respectively) were measured breath-by-breath, during the protocol, using a gas analyser (MetaMax 3B, Cortex Biophysik, Leipzig, Germany). Heart rate was continuously evaluated using an HR monitor (H7, Polar Electro Oy, Kempele, Finland). The integral of VO2 (L) and VCO2 (L) and the maximum 6-s moving average of relative VO2 (mL/kg.min), VE (L/min) and HR (bpm) were calculated for each set.
Muscle oxygenation: Throughout the protocol, oxygenated (O2Hb) and deoxygenated haemoglobin (HHb) were continuously monitored with a near-infrared spectroscopy device (Niro-200NX, Hamamatsu Phototonics, Hamamatsu, Japan) according with the manufacturer specifications. The integrals of O2Hb and HHb were calculated for each set of the protocol.
Neuromuscular fatigue assessment: Athletes executed a countermovement jump (CMJ) in a contact mat (Chronojump BoscoSystem, Software Version 2.2.0, Barcelona, Spain) before and after the exercise protocol, accessing values of jump height (JH). Three jumps were performed, separated by 30 s of rest, and the best jump was considered for analysis.
Data analysis: Power and sample calculations (G-Power, Version 3.1.9.2, Düsseldorf, Germany) were based on an effect size of 0.88 (McNaughton et al., 1997) for total work performed in the sprints, a power of 0.85 and a significance of 0.05. After the recruitment process, 12 athletes volunteered to participate in the study. One volunteer withdrew due to injury, leading to a sample size of 11 athletes. Statistical analysis was performed using the Statistical Package for the Social Sciences (IBM Corp, SPSS v27.0, Armonk, NY, USA) and R software (v4.2.0, Open-Source Code, General Public License). Normal distribution and sphericity were tested using Shapiro-Wilk's and Mauchly's tests, respectively. For variables with normal distribution, data was analysed using a two-way analysis of variance (ANOVA). Whenever a statistical significance was observed in the two-way ANOVA, post-hoc paired comparisons were performed with the Bonferroni correction. Statistical significance was set at p < 0.05. If normal distribution was not verified, the nparLD module of the R software was used to perform a non-parametric two-way ANOVA-type test and if any significant result was observed, a Friedman test and the post-hoc paired comparisons with the Bonferroni correction as well as a Wilcoxon test were performed. Statistical significance was adjusted according with the number of tests performed for each factor.
- Conditions
- Sodium Bicarbonate
- Being tested
- Sodium Bicarbonate, Placebo
- Keywords
- Ergogenic Dietary Supplement, Repeated Sprints Performance, Muscle Oxygenation, Oxygen Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium BicarbonateDietary supplement
Capsules containing 0.3 g/kg of body weight of sodium bicarbonate were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later.
PlaceboDietary supplement
Capsules containing 0.3 g/kg of body weight of celulose were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate - Placebo | Experimental | First exercise performance assessment after ingesting sodium bicarbonate. Second exercise performance assessment after ingesting placebo Receives: Dietary Supplement: Sodium Bicarbonate; Dietary Supplement: Placebo |
| Placebo - Sodium Bicarbonate | Experimental | First exercise performance assessment after ingesting placebo. Second exercise performance assessment after ingesting sodium bicarbonate Receives: Dietary Supplement: Sodium Bicarbonate; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak power output
Watt
Measured: 3 minutes through each set of the repeated sprints tasks
Mean power output
Watt
Measured: 3 minutes through each set of the repeated sprints tasks
Total Work
Joule
Measured: 3 minutes through each set of the repeated sprints tasks
Sprint Decrement
percentage of power decrease
Measured: 3 minutes through each set of the repeated sprints tasks
Secondary outcomes (8)
Countermovement jump height
cm
Measured: Before and after each repeated sprints tasks
Lactate accumulation
mmol.L-1
Measured: Before the repeated sprints tasks, between sets of the repeated sprints tasks, immediatly after the repeated sprints tasks, 2 minutes after the repeated sprints tasks
Oxygen uptake
mL/kg.min
Measured: 3 minutes through each set of the repeated sprints tasks
carbon dioxide production
Total L
Measured: 3 minutes through each set of the repeated sprints tasks
Ventilation
L/min
Measured: 3 minutes through each set of the repeated sprints tasks
Heart rate
bpm
Measured: 3 minutes through each set of the repeated sprints tasks
Changes in muscle oxygenated haemoglobin
Absorvance relative to rest obtained by Near InfraRed Spectroscopy
Measured: 3 minutes through each set of the repeated sprints tasks
Changes in muscle deoxygenated haemoglobin
Absorvance relative to rest obtained by Near InfraRed Spectroscopy
Measured: 3 minutes through each set of the repeated sprints tasks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start15 Oct 2021
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sodium BicarbonateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Monteiro, Faculdade de Motricidade Humana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098794
- Sponsor's protocol ID
- RepSprintsSodiumBicarbonate
- Status last verified
- Oct 2023
- First submitted
- 6 Oct 2023
- Last updated
- 25 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Sodium Bicarbonate Supplementation on Intense Exercise Performance
- ClinicalTrials.gov ID
- NCT06098794
- Acronym / sponsor ID
- RepSprintsSodiumBicarbonate
- Conditions
- Sodium Bicarbonate
- Keywords
- Ergogenic Dietary Supplement, Repeated Sprints Performance, Muscle Oxygenation, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a randomized, double-blind, placebo controlled, crossover trial. The study aimed to assess the effect of sodium bicarbonate on the ability to perform a repeated sprint task by female football players. The researches hypothesis was that sodium bicarbonate increases the ability to remove lactic acid from muscle cells reducing its intracellular accumulation and increasing energetic efficiency resulting in the increase of peak power output, mean power output, or total work or in the decrease of the sprint decrement in each set of the repeated sprints task.
Detailed description
Experimental design: The study consisted of a randomized, double-blind, controlled, crossover trial where 11 female football players performed, in a randomized order, two repeated sprints tasks in a cycle ergometer, after having ingested either sodium bicarbonate (SB) or placebo (PL). Body composition of the athletes was characterized by bioelectrical impedance analysis with a single frequency (50 kHz) device (BIA 101 Anniversary, Akern, Florence, Italy) before the exercise sessions. Data collection was separated by a period of at least one week within a period of time not exceeding one month and performed at the same time of the day for each participant. Data regarding performance, blood lactate accumulation, pulmonary gas exchange, heart rate (HR), muscle oxygenation and neuromuscular fatigue were collected during these two sessions.
Supplementation protocol: The participants ingested capsules containing 0.3 g/kg of body weight of SB or cellulose as PL divided into two doses. The first intake (0.2 g/kg) occurred 2 h before the beginning of the protocol, and the second (0.1 g/kg) occurred 1 h later. Possible gastrointestinal symptoms associated with supplement ingestion were controlled with a questionnaire based on the questionnaire applied by Miller et al. (2016).
Repeated sprints protocol: The RSA protocol was performed in a cycle ergometer (Monark Ergomedic 894 E, Monark Exercise AB, Vansbro, Sweden) and was composed of 3 sets of 6 sprints with 6 s duration with a workload of 4% of the body mass. Repetitions were separated by 24 s of active recovery, and participants were conceded 5 min of passive recovery to rest between sets. The protocol was preceded by a 5-min warm-up in which athletes pedalled at a speed of 60 to 70 rpm.
Performance Measurements: Performance was evaluated by monitoring peak power output, mean power output, total work and the sprint decrement in each set of the two repeated sprints task.
Blood lactate accumulation: Lactate concentration was assessed (Lactate Pro 2, KDK Corporation, Kyoto, Japan) in capillary blood from the ear lobe before the beginning of each protocol, 1 min after the end of each set, and at min 1 and every 2 min after the tasks were completed, until the value started to decrease. At the end of the tasks, the maximal values achieved were considered for analysis.
Pulmonary gas exchange and heart rate: Oxygen uptake, carbon dioxide production and ventilation (VO2, VCO2, VE, respectively) were measured breath-by-breath, during the protocol, using a gas analyser (MetaMax 3B, Cortex Biophysik, Leipzig, Germany). Heart rate was continuously evaluated using an HR monitor (H7, Polar Electro Oy, Kempele, Finland). The integral of VO2 (L) and VCO2 (L) and the maximum 6-s moving average of relative VO2 (mL/kg.min), VE (L/min) and HR (bpm) were calculated for each set.
Muscle oxygenation: Throughout the protocol, oxygenated (O2Hb) and deoxygenated haemoglobin (HHb) were continuously monitored with a near-infrared spectroscopy device (Niro-200NX, Hamamatsu Phototonics, Hamamatsu, Japan) according with the manufacturer specifications. The integrals of O2Hb and HHb were calculated for each set of the protocol.
Neuromuscular fatigue assessment: Athletes executed a countermovement jump (CMJ) in a contact mat (Chronojump BoscoSystem, Software Version 2.2.0, Barcelona, Spain) before and after the exercise protocol, accessing values of jump height (JH). Three jumps were performed, separated by 30 s of rest, and the best jump was considered for analysis.
Data analysis: Power and sample calculations (G-Power, Version 3.1.9.2, Düsseldorf, Germany) were based on an effect size of 0.88 (McNaughton et al., 1997) for total work performed in the sprints, a power of 0.85 and a significance of 0.05. After the recruitment process, 12 athletes volunteered to participate in the study. One volunteer withdrew due to injury, leading to a sample size of 11 athletes. Statistical analysis was performed using the Statistical Package for the Social Sciences (IBM Corp, SPSS v27.0, Armonk, NY, USA) and R software (v4.2.0, Open-Source Code, General Public License). Normal distribution and sphericity were tested using Shapiro-Wilk's and Mauchly's tests, respectively. For variables with normal distribution, data was analysed using a two-way analysis of variance (ANOVA). Whenever a statistical significance was observed in the two-way ANOVA, post-hoc paired comparisons were performed with the Bonferroni correction. Statistical significance was set at p < 0.05. If normal distribution was not verified, the nparLD module of the R software was used to perform a non-parametric two-way ANOVA-type test and if any significant result was observed, a Friedman test and the post-hoc paired comparisons with the Bonferroni correction as well as a Wilcoxon test were performed. Statistical significance was adjusted according with the number of tests performed for each factor.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate - Placebo | Experimental | Dietary Supplement: Sodium Bicarbonate, Dietary Supplement: PlaceboFirst exercise performance assessment after ingesting sodium bicarbonate. Second exercise performance assessment after ingesting placebo |
| Placebo - Sodium Bicarbonate | Experimental | Dietary Supplement: Sodium Bicarbonate, Dietary Supplement: PlaceboFirst exercise performance assessment after ingesting placebo. Second exercise performance assessment after ingesting sodium bicarbonate |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Football players
- Regularly training with a weekly microcycle consisting of 3 to 5 training sessions and 1 game at the weekend
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Injury occurrence in the month previous to data collection
- Ergogenic supplements consumption in the month previous to data collection
- Having known intolerance to sodium bicarbonate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium BicarbonateCapsules containing 0.3 g/kg of body weight of sodium bicarbonate were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later. | Dietary supplement | Placebo - Sodium Bicarbonate, Sodium Bicarbonate - Placebo |
| PlaceboCapsules containing 0.3 g/kg of body weight of celulose were ingested in two doses. The first intake (0.2 g/kg) was performed together with a carbohydrate-enriched meal 2 h before a repeated sprint exercise protocol, and the second (0.1 g/kg) occurred 1 h later. | Dietary supplement | Placebo - Sodium Bicarbonate, Sodium Bicarbonate - Placebo |
Primary outcome
Peak power output
Time frame: 3 minutes through each set of the repeated sprints tasks
Watt
Mean power output
Time frame: 3 minutes through each set of the repeated sprints tasks
Watt
Total Work
Time frame: 3 minutes through each set of the repeated sprints tasks
Joule
Sprint Decrement
Time frame: 3 minutes through each set of the repeated sprints tasks
percentage of power decrease
8 secondary outcomes
Countermovement jump height
Time frame: Before and after each repeated sprints tasks
Lactate accumulation
Time frame: Before the repeated sprints tasks, between sets of the repeated sprints tasks, immediatly after the repeated sprints tasks, 2 minutes after the repeated sprints tasks
Oxygen uptake
Time frame: 3 minutes through each set of the repeated sprints tasks
carbon dioxide production
Time frame: 3 minutes through each set of the repeated sprints tasks
Ventilation
Time frame: 3 minutes through each set of the repeated sprints tasks
Heart rate
Time frame: 3 minutes through each set of the repeated sprints tasks
Changes in muscle oxygenated haemoglobin
Time frame: 3 minutes through each set of the repeated sprints tasks
Changes in muscle deoxygenated haemoglobin
Time frame: 3 minutes through each set of the repeated sprints tasks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Sodium Bicarbonate
Not yet recruiting
Oral Sodium Bicarbonate for the Prevention of Labour Dystocia
Labour Dystocia
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Not yet recruiting
Sodium Bicarbonate Solution Enhances Lens Cleanliness in Magnetically Controlled Capsule Endoscopy
Health Adults
Active, not recruiting
Exercise-Induced Lactate and Cognitive Function (ExLBC)
Cognition, Sodium Bicarbonate
Recruiting
Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemotherapy
Oral Mucositis, Chemotherapy Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate in people with Sodium Bicarbonate, run by Faculdade de Motricidade Humana at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak power output (time frame: 3 minutes through each set of the repeated sprints tasks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2023.